Senior Manager, Clinical Trial Management

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $133.9k - $200.9k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Serve as the clinical trial lead responsible for planning, conduct, and operational oversight of clinical studies • Act as the primary clinical point of contact with the client • Collaborate with the Project Manager on monthly invoicing and clinical budget variance management • Develop study-related clinical documents, plans, forms, manuals, guidelines, trackers, slides, and training materials • Identify training needs for CRAs and third-party vendors and present training at Investigator and Study Kick-off meetings • Generate potential site lists and drive site feasibility • Identify enrollment risks and develop country recruitment and retention strategies • Manage communications and relationships with investigators and study teams throughout feasibility, start-up, enrollment, maintenance, and close-out • Lead internal clinical team meetings and set expectations for CRAs and CTAs • Address CRA and site questions and maintain FAQ logs • Support investigator meetings • Review or approve investigational product release packages • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies to meet study timelines and quality deliverables • Generate and use clinical metrics reporting to monitor study execution and communicate issues • Implement and manage the electronic Trial Master File (eTMF) • Collaborate on CAPA development, implementation, and closure • Assist sites, staff, and CRAs with GCP audit preparation • Support project-specific resourcing • Escalate CRA performance and site compliance issues • Collaborate with data management and CRAs to ensure data quality and cleaning timelines • Manage investigational product accountability and reconciliation • Assume project management responsibilities when a cross-functional Project Manager is not assigned • Support business development and marketing activities • Negotiate site budgets and investigator contracts when required • Review site visit reports and ensure monitoring follows the monitoring plan • Manage clinical vendors when required • Perform clinical data review and query generation when required • Potentially manage direct reports • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in a science or health-related field • Minimum 7 years of clinical research experience or proven competencies for the position, with significant clinical monitoring experience • Experience with Microsoft Office Products, including Outlook, Word, Excel, and PowerPoint • Advanced degree preferred • Mastery of ICH-GCP, relevant Precision SOPs, and regulatory guidance • Working knowledge of clinical management techniques and tools • Direct experience in a cross-functional environment • Proven functional management experience, including delegation and fostering cohesive team dynamics • Proven experience in planning, risk management, and change management • In-depth experience in pharmaceutical and/or device research • Demonstrated successful independent negotiation and conflict management strategies • Excellent communication, interpersonal, organizational, presentation, verbal, and written communication skills • Attention to detail and customer service demeanor • Ability to travel domestically and internationally, including overnight stays • Excellent time management, negotiation, critical thinking, decision-making, and analytical skills

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation • Other benefits